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Title |
Location |
Type |
Rate |
Apply Now |
| Manager,
Global Regulatory Operations 2808 |
Rochester,
NY |
Perm/Full |
$80,000 -
$100,000 |
Submit Resume |
Manager, Global Regulatory
The Manager, Global Regulatory Operations is
responsible for overseeing global regulatory
document management systems and processes,
implementing and maintaining an electronic
document and submission system, and managing the
preparation and compilation of regulatory
applications (e.g., INDs, BLAs, NDAs, and their
foreign equivalents) and related regulatory
submissions.
Job Duties:
Responsible for global regulatory document
management systems and processes, both
electronic and paper-based; managing regulatory
department files, archives and databases;
developing and promoting standard operating
procedures and processes related to regulatory
submission preparation and files.
Manage an electronic document and submission
system within regulatory and across R&D
functions. Liaise with Information Technology
and other related functions to develop and
implement electronic document management and
submission publishing systems.
Support regulatory submission planning and
scheduling in conjunction with project-based
Regulatory Affairs staff. Manage the submission
preparation and compilation process; manage the
quality review of technical documents to be
included in submissions to ensure proper format
and completeness of contents.
Develop and promote use of appropriate document
policies and standards to create
“submission-ready” documents by functional R&D
groups. Manage other Regulatory Operations
department activities as required. Supervise and
manage regulatory operations staff.
Qualifications Education:
Bachelor’s degree (or advanced degree) in a life
science discipline.
Experience:
8+ years of Regulatory Affairs experience with
specific experience in managing regulatory
operations, in implementing and operating an
electronic document management and submission
publishing system.
Special Skills:
Special skills include in-depth knowledge of
FDA, ICH and international regulations,
policies, and requirements with regard to
submission content and format, particularly the
Common Technical Document (CTD) format and
electronic CTD (eCTD) requirements.
Knowledge of the drug development process.
Computer proficiency in Microsoft Office
products, Adobe Acrobat, and familiarity with
XML concepts.
Demonstrated experience in project management.
Excellent oral communication skills and
technical writing skills.
Experience with the Documentum document
management system a strong plus.
Supervisory experience of staff in regulatory
operations a plus.
Specialized Training:
Specialized Regulatory training trough an
accredited professional regulatory organization
required (i.e., RAPS, DIA or AAPS). |
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